FDA recall D-0824-2020

Product

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16

Reason for recall

Subpotent: Out of specification for assay at the 12-month time point.

Distribution

Distributed Nationwide in the US

Key facts

Status

Terminated

Initiation date

2020-01-14

Report date

2020-02-05

Termination date

2021-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0824-2020